Legal Experimentation: Legal and Ethical Challenges to Evidence-Based Practice in Law, Medicine and Policymaking

Abstract

Recently, both legal scholars and lawmakers have called for evidence-based practice (EBP) across a variety of “practice” areas, including not only clinical medicine, health care delivery and public health practice, but also legal services, education, criminal justice, housing, environmental regulation and many other areas of law- and policy- making. Drawing on the most longstanding version of EBP — evidence-based medicine (EBM) — they reasonably argue that decisions affecting human welfare should be based on sound evidence about the comparative effects of alternatives. Rigorously studying the effects of an innovative practice on a small scale before implementing it more widely limits the extent of any negative impact it might have. And retrospective testing of already-accepted practices can identify ineffective and inefficient practices.

But EBM has faced substantial legal and ethical challenges. Regulations in place since the early 1980s — but, fortuitously, now being questioned by both scholars and regulators — often make it difficult to conduct the research (including RCTs, quality improvement/assurance, demonstration projects, analysis of existing data) necessary to inform EBP, not only in medicine but in other practice areas. On the other hand, conducting research and integrating research into practice settings that are traditionally understood to involve fiduciary relationships raise legitimate legal and ethical concerns.

This document highlights some of these legal and ethical questions and provides background on the relevant regulations; argues for the need to unite scholars interested in widespread EBP with scholars already working on the challenges to EBM in order to develop legal, ethical and effective approaches to achieving EBP that are suitable for diverse purposes; and discusses a workshop that aims to begin that process.

Keywords: evidence-based medicine, evidence-based practice, quality improvement, quality assurance, policy experiments, research ethics, Common Rule